Medyssey Spine Receives FDA 510(k) Clearance For Zenius(TM) Thoracolumbar Spinal System In Titanium Alloy (Ti6AL-4V ELI)
South Korea-based Medyssey Co., Ltd. announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius(TM) System in the United States in Q4. The Zenius(TM) System is a Ti alloy 5.5 mm Rod and Thoracolumbar Pedicle Screw Construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies.
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